PHASE II STUDY OF AMRUBICIN (AMR) FOR PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) AS THIRD-LINE OR FOURTH-LINE CHEMOTHERAPY: HOKKAIDO LUNG CANCER CLINICAL STUDY GROUP TRIAL (HOT) 0901

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Abstract

Background

Although an increasing number of NSCLC patients receive third-line chemotherapy with the established benefit of second-line chemotherapy, the role of cytotoxic agent in this setting has not yet been well defined prospectively. AMR, third-generation synthetic anthracycline agent, has found favorable clinical activity and acceptable toxicity for NSCLC as well as small cell lung cancer. This prospective trial was conducted to evaluate the efficacy and safety of AMR for NSCLC patients as third-line or fourth-line chemotherapy.

Methods

Eligible patients had a performance status 0 to 2, failure of second-line or third-line chemotherapy and adequate organ function. Patients received AMR 35 mg/m2 intravenously on days 1–3 every 3 weeks. The primary end point was disease control rate (DCR: CR + PR + SD). Secondary end points were overall survival (OS), progression-free survival (PFS), response rate (CR + PR) and toxicity profile.

Results

From August 2009 to May 2011, 41 patients were enrolled from 10 institutions. Patient characteristics were: male/female, 29/12; median age 66 (range 43–74); performance status 0/1/2, 16/24/1; adenocarcinoma/squamous cell carcinoma/large cell carcinoma/not other specified 30/8/2/1; EGFR mutation positive/negative/unknown 7/26/8; treatment lines 3rd/4th 26/15. The median number of treatment cycles was 2 (range 1–9). The objective responses were CR 0, PR 4, SD 22, PD 14 and NE 1, giving a DCR of 61.0% (95% CI, 46.0–75.9%). Overall response rate was 9.8% (95% CI, 0.6%–18.8%). Median PFS was 2.6 months, whereas the median survival time was not reached. Grade 3/4 hematological toxic effects were neutropenia (68%), anemia (12%), thrombocytopenia (12%) and febrile neutropenia (17%). Grade 3/4 non-hematological toxic effects were anorexia (12%), nausea (10%) and pneumonitis (2%). No treatment-related death was observed.

Conclusions

AMR shows significant clinical activity with acceptable toxic effects as third-line or fourth-line chemotherapy for advanced NSCLC.

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